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General Information

Fertinex has been approved as the first highly purified
follicle-stimulating hormone (FSH) that can be administered via
subcutaneous injection. Fertinex will be marketed for subjects
undergoing infertility treatments with Assisted Reproductive
Technologies (ART), such as In Vitro Fertilization (IVF), as well
as for infertile subjects with polycystic ovary disease (PCO)
1.

Because of its high purity, Fertinex can be self-administered
with a very small needle just under the skin (subcutaneous
injection), an additional improvement compared to older products
which must be injected deep into muscle tissue (intramuscular
administration) usually with the aid of the subject's
physician, nurse, or partner.

FSH is the primary natural hormone that stimulates development
and maturation of follicles, found in the ovaries, which contain
oocytes (eggs); during ovulation, egg(s) are released from the
follicles. Fertinex stimulates ovarian follicular growth in women
who do not have primary ovarian failure. In order to affect final
maturation of the follicle and ovulation in the absence of an
endogenous LH surge, human chorionic gonadotropin (hCG) must be
given following the administration of Fertinex when monitoring of
the patient indicates that sufficient follicular development has
occurred. There may be a degree of interpatient variability in
response to FSH administration.

Additional Information

Infertility affects about 10% of the reproductive-age population
in the United States., or about 5.3 million people, according to
the American Society for Reproductive Medicine (ASRM). Infertility
is commonly defined as the inability to conceive or carry a
pregnancy to term, and may be the result of various medical
conditions. Infertility affects both the male and female partners
equally.